Pharmaceutical Serialization Track & Trace

Transcription

1 Pharmaceutical Serialization Track & Trace Mike Salinas, M+W U.S., Inc. A Company of the M+W Group Dec 13, 2012 AGENDA The Global Counterfeit Drug Problem The Potential Market an International Focus! Industry Regulations Key Players in the Industry Cradle To Grave E Pedigree Serialized Solution Layered Model 3 Pieces to the Puzzle Serialization Reality 1

2 THE GLOBAL COUNTERFEIT DRUG PROBLEM A $200B Market Prompting massive demand dfor action: Patient Safety New & pending regulations Emerging requirement for product verification and authentication Much confusion & uncertainty THE POTENTIAL MARKET A INTERNATIONAL FOCUS! World wide Track & Trace Hot Spots Law in Place: Canada CA, USA Brazil Ghana Nigeria France Italy Greece Turkey China India Korea Japan Codification Guidelines (Product Type + Batch Information) Laws in Place Pending Regulations Different Categories of Applications Pending Regs: USA Mexico Columbia Chile Argentina Portugal Spain Belgium Slovenia Yugoslavia Romania Russia Egypt Saudi Arabia Malaysia Australia Serialization Guidelines (Mass Serialization/ Track & Trace) A constant global theme that is emerging The Requirement for PRODUCT VERIFICATION based on CODIFICATION & MASS SERIALIZATION This Global anti counterfeit packaging market is expected to reach $82.2B by

3 INDUSTRY REGULATIONS USA California is the first and only state that has imposed serialization mandates The California law requires: 50% of a manufacturer's products must be distributed with electronic pedigrees by 2015 The remaining 50% of the manufacturer s products must comply by 2016 Wholesalers and re packagers must accept and pass epedigrees by July 1, 2016 Pharmacies/pharmacy distribution centers must accept epedigrees by July 1, 2017 Manufacturer s must submit an outline of the product % make up by December 1, 2014 By unit volume By product package (sku) type By Drug Product family Nearly everyone in the U.S. pharmaceutical industry expects the FDA, with a congressional grant of authority or without, to require e Pedigrees nationally or even a more robust track and trace system so as to avert a patchwork of 50 state laws kicked off by California's action EUROPE Turkey has been out in front France a close second Legislature is developing a sound strategy REST OF THE WORLD THE China - centralized pedigree and serialization Brazil - pilot unit serialization and scale up over the next few years Approximately 50% of the industry now have at least one product line serialized KEY PLAYERS IN INDUSTRY The whole is more than the sum of its parts. ARISTOTLE, FROM METAPHYSICS BCE There are no shortage of g vendors offering technologies for new or retrofitted packaging lines 3

4 SERIALIZATION CHALLENGES ORGANIZATIONAL CONSTRAINTS: Lack of resources Inertia Mergers & acquisitions iiti Product/ technology rationalizations Outsourcing Scheduling Time on the Line GLOBAL INFRASTRUCTURE: The infrastructure to read the codes, etc. amongst the Supply Chain partners might not be in place to meet the deadlines FOR HELP Responsible person A tosses looming T&T deadline memo B into wastebasket C which causes board D to become unbalanced raising tack E to pop balloon F startling cat G who jumps up, pushing bellows H, thus blowing fan blades I which winds and shortens cord J lifting trough K, causing baseball L to roll down and drop onto PLAY button of cassette player M which turns on specially recorded tape message N which has been embedded with the subliminal message: CALL FOR HELP Thermoformer Cartoner 3. Checkweigher Vial Additional hardware and software technology to Code, Read, Verify and Track the product through the line Needle Vial Adapter 4. Case Packer 5. Palletizer Unit of Sale 5. Blister Packaging Line w/ Serialization, Track & Trace 4

5 CRADLE TO GRAVE E PEDIGREE Thinking outside the box PRESENT: Pharmaceutical Manufacturers and Packagers Focus Expand past the shop floor Address varying markets Integrate Coding, Serialization and Track & Trace solutions across the entire supply chain! THE PHARMACEUTICAL SUPPLY CHAIN PROPOSED: Full Implementation Requirement SERIALIZATION SOLUTION LAYERED MODEL EPCIS ERP MES HMI Wholesaler Plant A Shop Floor A1 Line A1-1 Global Serialization Data vault External Supply Chain Internal Supply (Enterprise) Chain A2 Plant B B1 Pharmacist Contractor B2 C1 Serialization Solution Cartoner Bundler Case Packer Palletizer EPCIS: EPC Information Services to enable disparate applications to leverage Electronic Product Code (EPC) data via EPC-related data sharing, both within and across enterprises. ERP: Enterprise Resource Planning MES: Manufacturing Execution System HMI: Human-Machine Interface of the Serialization application 5

6 3 PIECES TO THE PUZZLE: 1. M+W Life Sciences PLAN, DESIGN, CONSTRUCT, AND VALIDATE PRODUCTION FACILITIES Getting a serialized 2D bar code on a package achieves nothing if no one is equipped to read it. To exit the shop floor you need to add a DATA MANAGEMENT PLATFORM + SYSTEMS INTEGRATION services 2. Serialization Platform 3. Information Technology Track & Trace Anti-Counterfeiting Diversion Protection Cold Chain Tracking Data Gateway Verification Business Partners MES/WMS ERP Scanners EPCIS Regulatory Agencies Project based & enterprise specific platform customization for: Track & Trace Anti Counterfeiting Diversion Protection Recalls/ Returns Cold Chain Serialization e Submissions The Link To Full Implementation SERIALIZATION REALITY The Global Counterfeit Drug Market is huge and affects Patient Safety Counterfeit Drugs a very serious problem! Counterfeit drugs have Brand, Quality, and Regulatory implications as well. The inertia for Serialization Track & Trace is over Pharmais implementing Implementation seems to stop with the pharmaceutical companies 30% 50% of drugs are counterfeits US sales losses = $30B/year Investments 15%/year The market is disjointed & confused 6

7 THE CASE FOR STRATEGIC CONSULTING SERVICES Overall Strategy & Implementation Planning Engineering assessments Corporate Site and/or Line level Line Retrofit Evaluations URS and FRS development Serialization Awareness & Technology Training Proof of principle of pilot and implementation plan management Serialization Technology Vendor Evaluations, Recommendation & Selection THE CASE FOR TECHNOLOGY INTEGRATION SERVICES Device Level: o Encoding systems o Machine vision Packaging Line Level: Configuring the Serialization software to manage the: o Data o Aggregation o Product and line recipes, o Business logistics Enterprise Level: o Providing access between critical data points from various packaging lines to ERP, EPCIS, and other IT business systems o Capturing the data and providing a data repository e.g. SAP Aii/OER o Establishing and allocating serial numbers, and o Managing the process, work orders, and e pedigree 7

8 FAST FORWARD ENFORCEMENT CRYSTAL BALL: Push hback kfrom the Supply Time will tll tell Chain stakeholders Will US implementation be delayed? Will the law be challenged? hll Is there some middle of the road alternative? Mike Salinas Director of Manufacturing Technology M+W U.S., Inc. A Company of the M+W Group 285 Summer St. Boston, MA Mobile: Mike.Salinas@MWGroup.net 8